Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission

Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00963521

Enrollment

Registered

2009-08-21

Start date

2008-06-30

Completion date

Unknown

Last updated

2011-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

adult acute myelomonocytic leukemia (M4), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22)

Brief summary

RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

Detailed description

OBJECTIVES: Primary * Assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission. Secondary * Evaluate the emergence of an immune response. * Determine the relapse rate. * Assess the occurrence of residual disease. OUTLINE: Patients receive increasing doses of blastic cells transformed in vitro by autologous dendritic cells (1/3 subcutaneously and 2/3 IV) every 3 weeks for up to 5 doses.

Interventions

BIOLOGICALtherapeutic autologous dendritic cells

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of acute myelogenous leukemia (AML) * Myelomonocytic (M4) or monocytic (M5) subtype * In second complete remission (CR) or later following CR1 lasting ≤ 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation * No (15;17) translocation * No AML M3 * HLA-A2 positivity * CD14 ≥ 20% on peripheral blood mononuclear cells * Circulating blasts ≥ 10 x 109/L (collected prior to chemotherapy) available * Must not be eligible for HLA-matched allogeneic transplantation * No progressive disease PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Not pregnant or nursing * Fertile patients must use effective contraception * No contraindication to cytopheresis or chemotherapy * No HIV or HTLV positivity * No hepatitis B or C activation * No prior psychological disease * Not deprived of liberty and able to give consent * Must be able to speak and read French * No other cancer except for basal cell or cervical PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent participation in another clinical study

Design outcomes

Primary

Measure	Time frame
Adverse events at 6 months	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026